Market Authorization

 
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ATLANTA , July 31, 2014 /PRNewswire/ -- Alimera Sciences, Inc. (NASDAQ: ALIM) (Alimera), a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, today announced that the Danish Health and Medicines Authority has granted marketing authorization to ILUVIEN® for the treatment of vision impairment associated with chronic diabetic macular edema (DME) considered insufficiently responsive to available therapies.
Sign-up for Alimera Sciences' ILUVIEN® Receives Marketing Authorization In Denmark For The Treatment Of Chronic Diabetic Macular Edema investment picks
First Marketing Authorization Application for an Oncolytic Immunotherapy in the European Union THOUSAND OAKS, Calif.
Sign-up for Amgen Submits Marketing Authorization Application For Talimogene Laherparepvec To The European Medicines Agency investment picks
Represents First Marketing Authorization Application in the European Union for a PCSK9 Inhibitor THOUSAND OAKS, Calif.
Sign-up for Amgen Submits Marketing Authorization Application For Novel Investigational LDL Cholesterol-Lowering Medication Evolocumab To The European Medicines Agency investment picks
Regulatory News: Ipsen (Euronext: IPN; ADR: IPSEY) today announced that it has submitted a Supplemental New Drug Application to the U.S. Food and Drug Administration (FDA) for Somatuline ® Depot 120mg injection for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs). In the European Union, Ipsen has submitted national marketing authorization variations for Somatuline ® Autogel ® 120mg injection to the drug regulatory authorities in 25 countries of the European Union.
Sign-up for Ipsen submits marketing authorization applications in the US and Europe for Somatuline® (lanreotide) in the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs) investment picks
Ipsen Biopharmaceuticals, Inc., the U.S. affiliate of Ipsen (Euronext: IPN; ADR: IPSEY) today announced that it has submitted a Supplemental New Drug Application to the U.S. Food and Drug Administration (FDA) for Somatuline ® Depot 120mg injection for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs). In the European Union, Ipsen has submitted national marketing authorization variations for Somatuline ® Autogel ® 120mg injection to the drug regulatory authorities in 25 countries.
Sign-up for Ipsen submits marketing authorization applications in the U.S. and Europe for Somatuline® (lanreotide) in the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs) investment picks
The Medicines Company (NASDAQ:MDCO) today announced that the European Medicines Agency (EMA), the Committee for Medicinal Products for Human Use (CHMP), and the European Commission have granted market authorization renewal for Angiox® (bivalirudin) following a review of the latest clinical, safety, and efficacy data, as well as the Angiox risk management plan.
Sign-up for The Medicines Company Receives Market Authorization Renewal for Angiox® (Bivalirudin) from the European Medicines Agency and the European Commission investment picks
Sweden is latest country to grant marketing authorization ATLANTA , Sept.
Sign-up for Alimera Sciences' ILUVIEN® Receives Tenth National Marketing Authorization For The Treatment Of Chronic Diabetic Macular Edema investment picks
Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) today announced that the Marketing Authorization Application (MAA) for asfotase alfa, an investigational, first-in-class targeted enzyme replacement therapy for the treatment of hypophosphatasia (HPP), has been validated and granted accelerated assessment by the European Medicines Agency (EMA). The acceptance of this MAA marks the beginning of the review process in the European Union (EU) for this potential new treatment.
Sign-up for European Medicines Agency Accepts Marketing Authorization Application for Asfotase Alfa as a Treatment for Patients with Hypophosphatasia investment picks
Portugal approves reimbursement for ILUVIEN ATLANTA , July 28, 2014 /PRNewswire/ -- Alimera Sciences, Inc. (NASDAQ: ALIM) (Alimera), a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, today announced that the Norwegian Medicines Evaluation Board has granted marketing authorization to ILUVIEN® for the treatment of vision impairment associated with chronic diabetic macular edema (DME) considered insufficiently responsive to available therapies.
Sign-up for Alimera Sciences' ILUVIEN® Receives Marketing Authorization In Norway For The Treatment Of Chronic Diabetic Macular Edema investment picks
Cubist Pharmaceuticals, Inc. (NASDAQ:CBST) today announced that the European Medicines Agency (EMA) has accepted for review the Company’s Marketing Authorization Application (MAA) for its investigational antibiotic ceftolozane/tazobactam. Cubist is seeking approval of ceftolozane/tazobactam for the treatment of complicated urinary tract Infections and complicated intra-abdominal infections, with a decision from the European Commission (EC) expected during the second half of 2015.
Sign-up for Cubist Announces EMA Acceptance of Ceftolozane/Tazobactam Marketing Authorization Application for Review investment picks
- MAA submission triggers $5 million milestone payment to AcelRx REDWOOD CITY, Calif.
Sign-up for AcelRx and Grunenthal Announce Submission of European Marketing Authorization Application for ZALVISO™ investment picks
ATLANTA , June 23, 2014 /PRNewswire/ -- Alimera Sciences, Inc. (NASDAQ: ALIM) (Alimera), a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, today announced that the Italian Medicines Agency (Agenzia Italiana del Farmaco) has granted marketing authorization to ILUVIEN® for the treatment of vision impairment associated with chronic diabetic macular edema (DME) considered insufficiently responsive to available therapies.
Sign-up for Alimera Sciences' ILUVIEN® Receives Marketing Authorization In Italy For The Treatment Of Chronic Diabetic Macular Edema investment picks
BRISBANE, Calif., June 25, 2014 (GLOBE NEWSWIRE) -- Hyperion Therapeutics, Inc. (Nasdaq:HPTX) today announced that the European Medicines Agency (EMA) has completed technical and content validation and accepted the filing of the Marketing Authorisation Application (MAA) for RAVICTI (glycerol phenylbutyrate) Oral Liquid for the treatment of urea cycle disorders (UCDs). Acceptance of the MAA confirms that the submission is complete so as to permit a substantive review by the Rapporteurs and the Committee for Medicinal Products for Human Use (CHMP). "We are very pleased to receive MAA acceptance for review of RAVICTI and anticipate a CHMP opinion in the third quarter of 2015," said Donald J.
Sign-up for Hyperion Therapeutics Announces EMA Acceptance for Review of Marketing Authorization Application for RAVICTI(R) investment picks

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Market Authorization
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